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The Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Evecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

The Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Daily Wear Contact Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera. The Saview 55 Multifocal Contact Lens is available in an aspheric lens design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxvethyl methacrylate. methacrylic acid and diethlene glycol monomethacrylate, crosslinked with ethylene glycol dimethacrylate. The lens contains 55% water by weight. The lens is tinted using Pigment Blue 15.

The provided text is a 510(k) summary for a medical device (contact lens) and does not contain information about studies related to AI/ML device performance or acceptance criteria in the context of AI/ML.

Therefore, I cannot provide the requested information. The document pertains to a traditional medical device (contact lenses) and its substantial equivalence to predicate devices based on physicochemical properties and manufacturing processes, not on an algorithm's performance. There is no mention of acceptance criteria or studies involving artificial intelligence, machine learning, or similar computational methods.

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